FDA's Proposed Compliance "Revamp": What Does It Mean for the Agency, Industry, and Consumers?July 25, 2023
July 25, 2023
by Tim Philips
FDA Human Foods Program (HFP) Proposal Update
In a news release dated June 27, 2023, the Food & Drug Administration provided an update on its proposal to create a unified Human Foods Program (HFP), which includes a new model for the Office of Regulatory Affairs (ORA) affecting all FDA-regulated entities.
In describing the new model, FDA Commissioner Robert M. Califf, M.D., stated that ORA would be "…merging its current compliance functions into those of the new HFP and other agency product Centers." The stated purpose of the merger [of ORA and Center compliance functions] is to streamline operations and expedite decision-making. Califf calls it a "…once-in-a-generation opportunity to unify our field work with the priorities of program offices and Centers." Thus, the FDA believes this reorganization will enhance coordination, prevention, and response activities, enabling the agency to better support its public health mission.
Devoted FDA-watchers might view reorganization of the agency's compliance functions as mere bureaucratic personnel-shuffling; however, it is much more than that. This article explores the potential implications for the FDA, for industry, and for consumers, with an eye toward whether the revamp will improve FDA's operations and help the agency protect and promote public health.
The Centers and the Field
The relationship between FDA's Centers and the Office of Regulatory Affairs (i.e., "the field") is complicated. In most ways, it is a healthy partnership. ORA is "boots on the ground" in the agency's interactions with regulated industry, while the Centers provide direction and oversight and ensure consistent application of FDA policy across the nation. In the area of compliance - which includes advisory and enforcement actions - each organization has well-defined roles, and there are checks and balances built into the agency's procedures.
Compliance cases usually originate in ORA when violations are revealed during an inspection, a sample analysis, or a firm-initiated recall. Currently, ORA has their own compliance organization which is staffed by knowledgeable and experienced "Compliance Officers." Many Compliance Officers "grew up" in the agency as investigators, laboratory analysts, or supervisors in investigations. It is these field Compliance Officers who initiate and help manage compliance actions against violative companies and their products. Some compliance actions - such as warning letters, untitled letters, and regulatory meetings - take place with little or no Center involvement. More serious compliance cases - such as seizures, injunctions, and prosecutions - require detailed review, and ongoing involvement, of Center compliance staff.
It is common for ORA and a Center to disagree on whether to pursue a compliance action or to disagree on the type of action to pursue. Those disagreements usually lead to healthy discussion and improvements in FDA's handling of compliance cases. Picture a scenario where ORA recommends an injunction (to shut-down production of an illegal product), but the Center disagrees because they are aware of potential shortages that would be more dangerous than leaving an imperfect product on the market while corrections are made. In that example, FDA would correctly choose not to pursue a case, with real benefits to industry and consumers.
Unlike the scenario above, ORA / Center interactions can be inefficient or redundant, resulting in significant delays in handling compliance cases. If the relationship between ORA and the Center is conflict-ridden and dysfunctional, the agency can fail to act against unsafe or ineffective products and fail to hold violative companies accountable for breaking the law. Tragic situations like that appear to be the driving force behind FDA's proposed compliance revamp.
Agency, Industry, and Consumer Impacts
Under FDA's 2017 reorganization of ORA, dubbed "Program Alignment", the agency changed from geographic-based management to program-based management in order to mirror the organization of the Centers. Program Alignment also required strict specialization of all ORA employees to conduct work in only one Center area. Program Alignment also mandated parallel case review (versus traditional sequential review) by ORA and Center compliance staff. Now, fast forward to the proposed revamp. Incorporating ORA's compliance function, and the people who do the work, into the Centers is a logical expansion of Program Alignment, which was rooted in the belief (of FDA's top officials) that ORA needed better integration with the Centers.
That integration, however, is a tough pill for ORA loyalists to swallow because ORA enjoys and frequently exercises a degree of independence from the Centers. ORA compliance personnel are often more experienced and more proficient in compliance and enforcement matters than their colleagues in the Centers. ORA is comfortable using traditional compliance and enforcement tools (e.g., warning letters, recalls, seizures, injunctions, etc.) to help accomplish the agency's mission. ORA compliance staff are more experienced in monitoring open enforcement actions and in interacting with lawyers from FDA and the Department of Justice (DOJ). There is a wealth of institutional memory that is available only in ORA.
Industry officials should be concerned with the FDA's proposed revamp of the compliance function. Over the years, many companies have developed good relationships with their local ORA (a.k.a. "District") office of the FDA. District Compliance Officers are readily available to answer questions and provide assistance on matters such as 483 and warning letter responses, voluntary recalls, safety alerts, and emerging product issues. If the agency eliminates the ORA / District compliance organization, industry officials could be forced to deal directly with Center staff (in the Washington, DC area) for all compliance issues.
Similarly, consumers should object to any reorganization that eliminates or dilutes their access to local assistance from the FDA. ORA Compliance Officers routinely interact with consumers who contact the agency to ask questions about a product, file a complaint, get updates on the status of compliance actions, or inquire about FDA policy.
Proposed Compliance Requirements
For FDA's proposed revamp to improve the agency's handling of compliance cases, the reorganization must, at minimum:
- Retain a fully staffed and highly proficient corps of Compliance Officers by leveraging the existing talent and experience in ORA.
- Design an efficient and timely case processing procedure utilizing expertise in ORA and the Centers, being careful not to lose important elements like expert case development (now in ORA) and expert medical and scientific review (now in the Centers).
- Retain resources in ORA ("the field") so that industry and consumers can readily obtain local assistance on FDA compliance issues.
The FDA says it is on target to finalize its reorganization proposal, for both ORA and the unified HFP, this fall. That forecast is probably overly ambitious. The Agency is required to bargain the impact and implementation of the organizational changes with the labor unions (NTEU and AFGE) representing ORA compliance personnel. The FDA and the Unions will take this negotiation very seriously, and if there are delays in reaching an agreement, it will inevitably delay the reorganization.
It is too soon to predict the outcome of the FDA's compliance revamp. In a worst-case scenario, the agency squanders years of ORA field compliance experience, makes it more difficult for industry to interact with the agency, and exposes consumers to products that are less safe and effective. Best-case, FDA effectively integrates ORA and Center compliance staff, increases the efficiency of compliance case work, continues to interact well with industry and consumers, and protects all of us from adulterated and/or misbranded products.
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About the Author
Timothy Philips is a Biomedical Engineer who works as a Consultant for Gardner Law and as an Adjunct Professor at the University of St. Thomas in the School of Engineering / Regulatory Science program. Mr. Philips retired from the FDA in 2020 after 32+ years of service with the agency --- 12 years as a Field Investigator and 20 as a Compliance Officer --- all in the agency's Minneapolis District Office. In 2014, he was named ORA's Compliance Officer of the Year. Mr. Philips also served as the Chief Negotiator for the American Federation of Government Employees (AFGE) during FDA's Program Alignment reorganization in 2017.
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